Consumer Information on: VASCADE Vascular Closure System (VCS) - P120016
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: VASCADE Vascular Closure System (VCS)
PMA Applicant: Cardiva Medical, Inc.
Address: Cardiva Medical, Inc., 888 West Maude Avenue, Sunnyvale, CA 94085
Approval Date: January 31, 2013
Approval Letter: The approval letter will be available online.
What is it? The VASCADE Vascular Closure System (VCS) is designed to close a puncture site in the major artery of the thigh (femoral artery). The system is comprised of a delivery device and a collagen patch. Over time, the collagen patch breaks down and is absorbed into the body. The collagen patch is made from a fibrous material derived from cow (bovine) tissue.
How does it work? The physician uses the delivery device to place the patch inside the punctured tissue between the surface of the skin and the artery (tissue tract). The patch expands to fill the tissue tract and thereby helps the blood to clot and stops blood flow.
When is it used?
The VASCADE VCS is used to close a puncture site in the femoral artery in patients who have undergone a diagnostic cardiovascular catheter procedure (to make a clinical diagnosis) or an interventional cardiovascular catheter procedure (for instance, to open a blocked coronary artery in the heart with a balloon and place a stent in the opened artery), using a 5F, 6F, or 7F procedural sheath.
What will it accomplish? The VASCADE VCS reduces the time for blood to clot and shortens the time for patients to be able to walk after diagnostic and interventional procedures. It also reduces the length of time it takes for patients to be eligible for discharge from the hospital after diagnostic procedures.
When should it not be used? The VASCADE VCS should not be used in patients with a known allergy to products derived from cow tissue.
Additional information: The Summary of Safety and Effectiveness Data and labeling will be available online.